Job Information
Cambrex High Point Validation Engineer in Charles City, Iowa
Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
As a part of the Engineering Department, the Validation Engineer will assist with compliance of validation activities relating to facility and equipment qualifications throughout the plant. Interaction with all areas of the manufacturing plant site will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines.
Responsibilities
Developing IQ, OQ, PQ protocols by utilizing the Company’s standardized validation system to ensure consistency
Working to continuously improve/update protocols to meet cGMP requirements
Coordinating equipment and facility qualification activities between Engineering, Maintenance, QA, Operations, construction firms, and validation contractors
Coordinating with Maintenance to repair system failures
Maintaining validated systems as required by change control
Performing small validation studies
Driving revalidation efforts to ensure systems continue to meet regulatory requirements
Performing or overseeing execution of protocols, including gathering IQ documentation, resolving exceptional conditions, preparing final qualification reports, etc.
Defending qualifications during FDA and customer audits
Qualifications/Skills
Knowledge of cGMP equipment and manufacturing operations
Demonstrated proficiency in windows based environment including word processing, spreadsheet, and data base programs
Desire to work with or knowledge of Distributive Control Systems
Education, Experience & Licensing Requirements
BS Chemical Engineering or other Engineering discipline preferred
2 or more years of experience in API manufacturing and/or pilot plant environment highly preferred
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
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